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Roche’s Faricimab Shows Sustained Vision Benefits in Phase III Study for Retinal Vein Occlusion
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Swiss pharmaceutical giant Roche (SWX: ROG) has released interim Phase III data for its bispecific antibody (BsAb) Vabysmo (faricimab) in the treatment of macular edema resulting from branch and central retinal vein occlusion (BRVO and CRVO). The biologic demonstrated significant vision improvements, with gains of 17 to 19 letters on…
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CDE Reports 35.84% Increase in Drug Filings for 2023 with Focus on Innovation and Rare Diseases
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The Center for Drug Evaluation (CDE) has released its annual drug review report for 2023, highlighting a continued increase in drug regulatory filings. The CDE accepted 18,503 filings of various types, marking a 35.84% year-on-year increase. Within this figure, 3,745 filings required no technical review for direct administrative approval, an…
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J&J’s Gene Therapy for X-linked Retinitis Pigmentosa Receives CDE Nod for Breakthrough Designation
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s AAV5-hRKp.RPGR (JNJ-5340, botaretigene sparoparvovec) intraocular injectable solution is on track to receive breakthrough therapy designation (BTD). This product, an adeno-associated virus vector (AAV) based gene therapy co-developed with MeiraGTx Holdings plc, is aimed at…
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German Tech Giant Merck Launches Digital Hub in Singapore to Boost Healthcare and Semiconductor Research
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Merck KGaA (ETR: MRK), a leading German technology company, last week inaugurated a digital hub in Singapore, marking its first such initiative outside of Europe and the US. This new digital hub will leverage collaboration platforms Syntropy and Athinia to enhance data analytics capabilities, aiming to spur innovation and research…
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Johnson & Johnson’s Talquetamab and Daiichi Sankyo’s Enhertu Eye Priority Review in China
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s Talvey (talquetamab) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) are on track to receive priority review statuses. Talquetamab, a bispecific GPRC5D-directed CD3 T-cell engager, is in development for the treatment of adult patients with recurrent/refractory…
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Biogen Discontinues Aduhelm Development, Redirects Focus to Other Alzheimer’s Therapies
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Biogen (NASDAQ: BIIB) has announced its decision to discontinue the development and commercialization of its Alzheimer’s disease (AD) drug Aduhelm (aducanumab), including a Phase IV post-marketing confirmatory study that was necessary to upgrade the treatment’s accelerated approval in the US. This move will incur USD 60 million in close-out costs…
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Beckton Dickinson’s Q1 Results Affected by Volume-Based Procurement, Life Sciences Growth
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US-based medical technology company Beckton Dickinson (BD; NYSE: BDX) has reported its financial results for the first quarter of the fiscal year 2024, ending December 31, 2023. In constant currency terms, sales increased by 1.6% year-on-year (YOY) to USD 4.7 billion. Breaking down the figures by business segment, BD Medical,…
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SciClone and Menarini File for Import License of Antibacterial Drug Vaborem in Macau
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SciClone Pharmaceuticals Inc (HKG: 6600) has announced that its Italy-based strategic partner Menarini has submitted an import drug pre-license filing for Vaborem (meropenem vaborbactam) in Macau. The company is seeking regulatory approval for the new antibacterial drug to treat complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), and complicated complex urinary…
